Logo 1 Logo 2

Clinical Trial Details

Trial ID: L6439
Source ID: NCT03313297
Associated Drug: Azd4017
Title: Glucocorticoids and Skin Healing in Diabetes (GC-SHealD)
Acronym: GC-SHealD
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: AZD4017|DRUG: Placebo
Outcome Measures: Primary: Skin 11β-HSD1 activity, Enzyme activity radioassay to evaluate AZD4107 efficacy in skin, Change between day 0 and day 28 | Secondary: Urinary cortisol / cortisone metabolites, Urine samples for tetrahydrocortisol / tetrahydrocortisone metabolite ratios to evaluate systemic AZD4107 efficacy, Change between day 0 and day 35|AZD4017 in plasma, Quantification of AZD4017 concentration in plasma to evaluate systemic AZD4107 exposure, Change between day 0 and day 28|AZD4017 in skin, Quantification of AZD4017 concentration in plasma to evaluate skin AZD4107 exposure, Change between day 0 and day 28|Discontinuation due to Adverse Event, Adverse Event-related participant withdrawals to evaluate safety, Day 42|Body mass index, Body mass index to evaluate safety, Change between day 0 and day 35|Waist-hip ratio, Waist-hip ratio to evaluate safety, Change between day 0 and day 35|Blood pressure (sphygmomanometer), Blood pressure to evaluate safety, Change between day 0 and day 35|Sudomotor function, Conducted with a Sudoscan device to measure c-fiber innervation in hands and feet for skin function, Change between day 0 and day 35|Skin hydration, Conducted with a Corneometer device to measure skin water content for skin function, Change between day 0 and day 35|Epidermal barrier function, Conducted with a Tewameter device to measure skin trans-epidermal water loss for skin function, Change between day 0 and day 35|Epidermal barrier integrity, Conducted by tape tripping to a pre-determined trans-epidermal water loss rate for skin function, Change between day 0 and day 28|Skin thickness, Conducted by Optical Coherence Tomography imaging for skin function, Change between day 0 and day 35|Wound healing, Conducted by Optical Coherence Tomography imaging for skin function, Change between day 0 and day 2|Wound healing, Conducted by Optical Coherence Tomography imaging for skin function, Change between day 0 and day 7|Wound healing, Conducted by Optical Coherence Tomography imaging for skin function, Change between day 28 and day 30|Wound healing, Conducted by Optical Coherence Tomography imaging for skin function, Change between day 28 and day 35|Skin RNA-seq gene expression profiling, For skin function, Change between day 0 and day 28
Sponsor/Collaborators: Sponsor: University of Leeds
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 28
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-04-10
Completion Date: 2019-03-13
Results First Posted:
Last Update Posted: 2019-03-22
Locations: Leeds Teaching Hospitals Trust, Leeds, LS9 7TF, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03313297